Impact of Virtual Reality on Anxiety and Pain During Implantation of Cardiac Implantable Electronic Devices (CIED)

NCT ID: NCT07250282

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-05-01

Brief Summary

Purpose:

This study aimed to evaluate whether virtual reality technology positively affects patients' pain and anxiety throughout the entire procedure of implantation of cardiac pacemakers, defibrillators, or cardiac resynchronisation therapy.

Detailed Description

Methods:

From January 2024 to Mai 2025, 100 Patients undergoing implantation of cardiac single-chamber or dual-chamber pacemakers or defibrillators and cardiac resynchronisation therapy were included in this study. Patients were randomly assigned to either a control group (n=50) or an intervention group (n=50). The control group received standard preoperative care and local anaesthesia using lidocaine. A virtual reality headset was used in the intervention group in addition to the standard preoperative care and local anaesthesia during the procedure. The procedure was performed in all patients using standard preparation and cephalic vein cutdown. The State-Trait Anxiety Inventory-State (STAI-S) questionnaire was filled out by patients pre- and postoperatively to determine their anxiety levels before and during the procedure.

Conditions

Anxiety; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

The patients in control arm received the standard preoperative care using local anesthesia

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention group

The patients in intervention arm received a virtual reality headset in addition to the standard care using local anesthesia

Group Type: EXPERIMENTAL

Virtual reality headset

Intervention Type: OTHER

A virtual reality headset was used during the study with the purpose of distracting the patients from painful and stressful stimuli in the operation room to decrease their anxiety and pain perception

Interventions

Virtual reality headset

A virtual reality headset was used during the study with the purpose of distracting the patients from painful and stressful stimuli in the operation room to decrease their anxiety and pain perception

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Indication for implantation of a cardiac pacemaker, ICD, or CRT device due to one of the following:
• Complete heart block (AV block III°)
• Symptomatic bradycardia due to sinus node dysfunction
• Tachy-brady syndrome
• Atrial fibrillation with slow ventricular rate
• Symptomatic bradycardia due to AV block II° type Mobitz
• Secondary prevention of sudden cardiac death due to ventricular tachycardia
• Primary prevention in patients with heart failure with reduced ejection fraction
• Primary prevention in patients with heart failure with reduced ejection fraction and complete left bundle branch block
• "Pace and ablate" strategy for therapy-resistant persistent atrial fibrillation
• Need to Upgrade to CRT-P due to a high percentage of right ventricular pacing

Exclusion Criteria

• Intolerance or inability to wear the VR headset
• Significant language barrier preventing consent or cooperation
• Need for deep sedation or general anesthesia for the procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhammed Kurt

OTHER

Sponsor Role: lead

Responsible Party

Muhammed Kurt

Attending physician, Department of Cardiology and Vascular Medicine, University Hospital Essen

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

West german heart and vascular center, University hospital Essen,

Essen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

23-11442-BO

Identifier Type: -

Identifier Source: org_study_id